Off-Label Use and Safety of Drug Use in Vascular Anomalies.
Dermatology
; 237(4): 649-657, 2021.
Article
en En
| MEDLINE
| ID: mdl-33823514
ABSTRACT
BACKGROUND:
Off-label drug use is associated with an increased risk of adverse drug reactions. It is common in pediatrics and in rare diseases, which are two characteristics applying to vascular anomalies (VA).OBJECTIVES:
The aim of this work was to quantify off-label drug use in VA and assess its safety.METHODS:
A review was conducted to extract a list of drugs used in VA management. A drug was considered to have significant safety concerns if a black box warning was present or if a serious adverse drug reaction (SADR) was reported in at least 1% of the patients (SADR is defined as a noxious and unintended response to a drug that occurs at any dose and results in hospitalization, prolongation of existing hospitalization, congenital malformation, persistent or significant disability or incapacity, life-threatening condition, or death). The labelling status and safety of each drug was assessed based on the product monograph, Micromedex, and the FDA data.RESULTS:
We found that 98.9% of the inventoried drugs were used off-label or unlicensed for VA management. Only the oral solution of propranolol hydrochloride (Hemangeol®) for the treatment of infantile hemangiomas is approved. Significant safety issues concerned 73% of the drugs and were more frequent among systemic than locally delivered drugs.CONCLUSIONS:
Off-label drug use in VA is the rule and not the exception. Significant safety concerns are common. It is necessary to carefully weigh risk and benefits for every patient when using systemic and local treatments carrying safety concerns. Patients should be openly informed and involved in the decision-making process.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Contexto en salud:
2_ODS3
/
6_ODS3_enfermedades_notrasmisibles
/
7_ODS3_muertes_prevenibles_nacidos_ninos
Problema de salud:
2_muertes_prevenibles
/
6_congenital_chromosomal_anomalies
/
7_neonatal_care_health
Asunto principal:
Vasos Sanguíneos
/
Etiquetado de Medicamentos
/
Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos
/
Uso Fuera de lo Indicado
Tipo de estudio:
Prognostic_studies
Límite:
Humans
Idioma:
En
Revista:
Dermatology
Asunto de la revista:
DERMATOLOGIA
Año:
2021
Tipo del documento:
Article
País de afiliación:
Canadá